| Conditions: |
|
Breast Cancer - Healthy Volunteer |
| Purpose: |
|
Background:
- Blister fluid contains many of the same biomarkers (substances that can be used to
determine the effects of certain kinds of treatments) as blood and urine samples,
particularly regarding changes in the skin.
- The Radiation Oncology Branch and others are conducting research studies that require
blood and urine samples from healthy volunteers and from patients with cancer. In
addition to these samples, researchers would like to collect the fluid from blisters to
examine markers of inflammation in the skin.
Objectives:
- To compare blood, urine, and blister fluid samples of patients with cancer who are
undergoing radiation therapy to that of volunteers without cancer who will not be
receiving radiation therapy.
- To gather more information about the effects of radiation therapy on the skin and body
fluids of individuals.
Eligibility:
- Patients 18 years of age and older who will be receiving radiation therapy for either
breast or prostate cancer.
- A separate group of healthy volunteers will also participate in this study.
Design:
- Physical examination and blood samples to determine eligibility for the study.
- Blister induction, conducted before the start of radiation treatment, at completion of
radiotherapy (last day of treatment), and at a visit 12 months after the end of
radiation treatment.
- Blisters will be created through the use of a suction blister device on the hip (for
patients with prostate cancer) or on the treated breast or location of removed breast
(for patients with breast cancer).
- Blisters will take approximately 30 minutes to form, and fluid will be removed with a
needle and syringe.
- Blood and urine samples will also be collected at this time.
- Radiation treatment for breast or prostate cancer will be conducted according to
standard procedures, or as directed by a separate research protocol.
- Evaluations during the treatment period:
- Physical examination, including vital signs and body weight checks, and pregnancy test
for women who can become pregnant.
- Blood and urine tests.
- Disease evaluation.
- Post-treatment evaluations:
- Clinic visits at months 1, 3, 6, 9, and 12 after the end of radiation therapy for
physical examination and disease assessment.
- Study will end 1 year after the final radiation treatment, upon the collection of the
final (third) blister fluid sample.
|
| Study Summary: |
|
BACKGROUND:
Blister fluid has been used to measure cytokine expression, proteomic profiles, and
pharmacokinetics in a variety of disease states.
Blister fluid inside radiation treatment fields has been shown to have altered expression of
cytokines and products of collagen metabolism.
Evaluation of blister fluid in normal skin inside and outside the radiation field may allow
the development of a minimally invasive marker of radiation exposure or damage induced by
radiation in irradiated skin.
OBJECTIVES:
This protocol will evaluate the ability to determine a cytokine pattern and global changes
at the protein level measured in blister fluid that correlates with radiation exposure,
absorbed skin dose, or skin toxicity from patients receiving radiation.
ELIGIBILITY:
Patients in whom radiotherapy is required for standard management of their breast or
prostate cancer.
Healthy volunteers with no history of cutaneous inflammatory condition of the skin such as
eczema, or psoriasis.
DESIGN:
This protocol is designed to evaluate blister fluid in and out of the radiation field in
patients that are receiving radiation therapy and in healthy volunteers.
Patients will undergo blister induction and blister fluid collection prior to treatment
outside of the radiation field, and after completion of radiation within the radiation
field.
Blisters will be induced in a non-sun exposed area and if possible in matched sites (i.e.
left and right).
|
| Criteria: |
|
- INCLUSION CRITERIA:
2.1.1.1 Histological diagnosis: Pathologically confirmed diagnosis of 1) invasive breast
cancer, 2) ductal carcinoma in situ, or 3) adenocarcinoma of the prostate.
2.1.1.2 Patients in whom the management of the histologic diagnosis will include radiation
treatment as part of standard clinical management.
2.1.1.3 Patients in whom the extent of disease is considered local or locoregional (ie.
requiring definitive radiotherapy to the breast or prostate).
2.1.1.4 Patients must be older than 18 years of age.
2.1.1.5 Patients must have a primary medical or surgical oncologist in the community or at
NCI who is wiling to collaborate with the ROB staff in the clinical management of the
patient.
2.1.1.6 Patients of childbearing or child- fathering potential must be willing to use a
medically acceptable form of birth control, which includes abstinence, while they are
being treated with radiotherapy on this study.
2.1.1.7 Patients must have an ECOG performance status of 0-2 and a life expectancy greater
than 12 months.
EXCLUSION CRITERIA:
2.1.2.1 Patients with a history of chronic skin disease such as psoriasis, eczema, or
history of keloid formation.
2.1.2.2 Patients requiring concurrent use of topical steroids
2.1.2.3 Patients requiring concurrent use of glucocorticoid therapy.
2.1.2.4 Patients who have received topical or systemic chemotherapy within 4 weeks of
enrollment (not including hormonal agents such as antiandrogens, GnRH agonists, aromatase
inhibitors, tamoxifen, and similar agents) are excluded.
2.1.2.5 Patients requiring concurrent chemotherapy with radiotherapy except as noted in
2.1.2.3 are excluded.
2.1.2.6 Patients with a history of lupus erythematosis, scleroderma, ataxia telengiectasia
or other known hypersensitivity to therapeutic radiation.
2.1.2.7 Patients with prior radiotherapy to the site which would be used for blister
induction.
2.1.2.8 Patients who are pregnant because of the potential mutagenic effects of radiation
on a developing fetus or newborn.
2.1.2.9 Patients with unrelated systemic illness which in the judgment of the Principal
Investigator (PI) would compromise the patient's ability to tolerate this therapy or are
likely to interfere with the study procedures or results.
2.1.2.10 Patients who are in the estimation of the PI, deemed unable or unlikely to adhere
to protocol treatment.
2.1.2.11Patients with significant skin atrophy that would interfere with blister
formation.
2.1.2.12Breast cancer patients in whom the site of radiotherapy includes a myocutaneous
flap or skin graft.
ELIGIBILITY CRITEREIA FOR HEALTHY VOLUNTEERS:
INCLUSION CRITERIA:
2.2,1.1 Healthy volunteers older than 18 years of age.
2.2.1.2 Ability to provide informed consent.
EXCLUSION CRITERIA:
2.2.2.1 History of chronic skin disease such as psoriasis, eczema, or history of keloid
formation.
2.2.2.2 Concurrent use of glucocorticoid therapy.
2.2.2.3 History of lupus erythematosis, scleroderma, ataxia telengiectasia or other known
hypersensitivity to therapeutic radiation.
2.2.2.4 Prior radiotherapy to the site which would be used for blister induction (for
benign or malignant causes).
2.2.2.5 Unrelated systemic illness which in the judgment of the Principal Investigator
(PI) would compromise the patient's ability to tolerate blister induction or are likely to
interfere with blister healing, the study procedures, or the study results.
2.2.2.6 Darkly pigmented skin in whom pigmentation changes are a likely complication
2.2.2 7 Significant skin atrophy that would interfere with blister formation.
|
| NCT ID: |
|
NCT00923104 |
| Primary Contact: |
|
Principal Investigator
Deborah E Citrin, M.D.
National Cancer Institute (NCI)
Sharon L Smith, R.N.
Phone: (301) 451-8905
Email: smiths@mail.nih.gov
|
| Backup Contact: |
|
Email: citrind@mail.nih.gov
Deborah E Citrin, M.D.
Phone: (301) 451-8973
|
| Location Contact: |
|
Bethesda, Maryland 20892
United States
For more information at the NIH Clinical Center contact National Cancer Institute Referral Office
Phone: (888) NCI-1937
Site Status: Recruiting |